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Completed

NCT Number: NCT03884231

A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.

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Key information

Conditions

Movement Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Dystonia Essential Tremor Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Tremor

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Gabriel Montpied, Clermont-Ferrand, Auverg N, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure.
  • Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use.
  • Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinician's Manual. Anxiolytics and patient's regular medications may be administered, provided Instructions For Use (IFU) criteria are met.
  • Subject is willing and able to comply with study requirements.

Exclusion criteria

  • Subject has another implanted device (active or passive implanted device) that prohibits safe scanning.
  • Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
  • Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
  • Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Subject is currently participating in another clinical investigation that may confound the results of this study.

Treatment and study plan

Infinity DBS System with MR Conditional labelling

Device

Patients implanted with the Infinity DBS system with MR Conditional labeling

Primary outcomes

  1. Rate of MRI-related Adverse Events

    Time frame: From MRI procedure through 1 month post-MRI procedure

    Any adverse event that was included in the primary endpoint analysis, if it:

    • Was classified as being MRI-related (as determined by the CEC), occured during or after the MRI procedure, and cannot be attributed to any other cause; and
    • Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and
    • Met the criteria for serious adverse event or was a non-serious adverse event that was the result of irrecoverable failure of therapy delivery or device communication.

Secondary outcomes

  1. Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode

    Time frame: Immediately after the MRI scan

    Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful MRI mode 'turn on/off' functionality of the MRI mode was assessed.

  2. Rate of Successful 'Turn on/Off' Functionality for the Stimulation

    Time frame: Immediately after the MRI scan

    Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful 'turn on/off' functionality for the stimulation was assessed.

  3. Rate of Successful Adjustments to the Stimulation Amplitude

    Time frame: Immediately after the MRI scan

    Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful adjustments to the stimulation amplitude was assessed.

  4. Rate of Successful Interrogation and Download of the IPG Parameters

    Time frame: Immediately after the MRI scan

    Secondary endpoints were evaluated after the MRI scan on subjects who were scanned with a full system configuration. Rate of successful interrogation and download of the IPG parameters was assessed.

  5. Rate of Successful Ability to Obtain Lead Impedance Measurements

    Time frame: Immediately after the MRI scan

    Secondary endpoints were evaluated after the MRI scan on subjects, who were scanned with a full system configuration. Rate of successful ability to obtain lead impedance measurements was assessed.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 21, 2019
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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